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首页> 外文期刊>JAIDS: Journal of acquired immune deficiency syndromes >Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naive subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934.
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Development of HIV-1 drug resistance through 144 weeks in antiretroviral-naive subjects on emtricitabine, tenofovir disoproxil fumarate, and efavirenz compared with lamivudine/zidovudine and efavirenz in study GS-01-934.

机译：在研究GS-01-934中，与拉米夫定/ zidovudine和efavirenz相比，天真的抗逆转录病毒受试者对恩曲他滨，替诺福韦二吡呋酯富马酸酯和依非韦伦的抗HIV-1药物耐药性的发展，持续了144周。

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Study 934 was an open-label, randomized Phase III study of emtricitabine + tenofovir DF + efavirenz (FTC + TDF + EFV) compared with lamivudine + zidovudine + efavirenz (3TC + ZDV + EFV) in antiretroviral therapy-naive HIV-1 infected subjects. Baseline genotyping revealed the presence of primary nonnucleoside reverse transcriptase inhibitor resistance (NNRTI-R) in 22 of 509 enrolled patients (4.3%, 11 subjects in each group). The 487 subjects without baseline NNRTI-R formed the primary efficacy population (modified intent-to-treat population). Through 144 weeks, 50 of 487 modified intent-to-treat subjects (FTC + TDF + EFV, n = 19; 3TC + ZDV + EFV, n = 31) were analyzed for resistance development after virologic failure. NNRTI-R, primarily the K103N mutation, was the most common form of resistance that developed in both groups. No subject on FTC + TDF + EFV developed the K65R mutation. Significantly fewer subjects on FTC + TDF + EFV compared with 3TC + ZDV + EFV developed the M184V/I mutation (two versus 10, respectively, P = 0.021). Thymidine analog mutations developed in two subjects on 3TC + ZDV + EFV. Subjects with baseline NRTI genotypic resistance (TAMs, n = 13) or non-B HIV-1 subtypes (n = 28) showed no evidence of reduced treatment responses in either group. Nine of 22 patients with baseline NNRTI-R experienced virologic failure (FTC + TDF + EFV, n = 4; 3TC + ZDV + EFV, n = 5); seven of nine developed M184V/I and/or additional NNRTI-R, but none developed K65R. Baseline NNRTI-R was significantly associated with virologic failure in both groups (P < 0.001).
机译：研究934是一项针对未经抗逆转录病毒治疗且未感染HIV-1的受试者的恩曲他滨+替诺福韦DF +依非韦伦（FTC + TDF + EFV）与拉米夫定+齐多夫定+依非韦伦（3TC + ZDV + EFV）进行的一项开放标签，随机III期研究。基线基因分型显示，在509名登记患者中有22名患者存在原发性非核苷逆转录酶抑制剂耐药性（NNRTI-R）（4.3％，每组11名受试者）。没有基线NNRTI-R的487名受试者构成了主要疗效人群（改良的意向治疗人群）。在144周内，分析了487名经修饰的意向治疗受试者（FTC + TDF + EFV，n = 19; 3TC + ZDV + EFV，n = 31）中的50名病毒学衰竭后的耐药性发展。 NNRTI-R主要是K103N突变，是两组中最常见的抗药性形式。 FTC + TDF + EFV上没有受试者发生K65R突变。与3TC + ZDV + EFV相比，使用FTC + TDF + EFV的受试者发生M184V / I突变的人数明显减少（分别为2对10，P = 0.021）。在3TC + ZDV + EFV的两个受试者中发生了胸苷类似物突变。具有基线NRTI基因型耐药性（TAMs，n = 13）或非B HIV-1亚型（n = 28）的受试者在两组中均未显示治疗反应降低的证据。 22名基线NNRTI-R患者中有9例发生病毒学衰竭（FTC + TDF + EFV，n = 4; 3TC + ZDV + EFV，n = 5）; 9个开发中的7个开发了M184V / I和/或其他NNRTI-R，但没有开发出K65R。两组的基线NNRTI-R均与病毒学衰竭显着相关（P <0.001）。

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